Doctors: FDA's plastic surgery follow-up plan impractical

With silicone breast implants back on the market, a debate over follow-up care is roiling the plastic surgery community, even as more women are choosing to have their breasts surgically enlarged.

When the Food and Drug Administration decided in November to again allow the use of silicone for breast augmentation, it did so provided that manufacturers instruct doctors to advise patients they will need a biannual MRI to check for ruptures, and if one is detected, to advise them the implants should be removed.

But some surgeons are criticizing the recommendations, saying they are bureaucratic and unscientific and that they interfere with their ability to tailor diagnosis and treatment to each patient. Some said they would not recommend the MRI, while others said they would follow the recommendations.

"The majority of plastic surgeons, even 99 percent of surgeons, would say there are problems with the directions," said Dr. Scott L. Spear, chairman of plastic surgery at Georgetown University Hospital.

He reported that most of about 150 doctors surveyed at a meeting of the American Association of Plastic Surgeons, a group of leading physicians, said they disagreed with them.

Lawsuits

Other surgeons said that doctors should follow the directions because much remains unknown about the durability and rate of rupture of silicone implants, which were the subject of controversial class-action suits in the 1990s.

"If people blow these tests off, it will be detrimental from a scientific standpoint," said Dr. V. Leroy Young, a plastic surgeon in St. Louis. "Patients will be walking around with failed implants and not know about it." He said ignoring the directions could increase patient risk, and he would insist his patients have the tests.

The FDA, criticized by some health advocates for allowing the silicone implants back onto the market, said it would monitor whether its recommendations were being followed.

"We are certainly going to be looking into the compliance with the MRIs by doctors and patients," said Donna-Bea Tillman, director of the FDA's office of device evaluation.

Tillman said the agency had determined that silicone-gel-filled implants are safe and effective for women 22 or older who receive the appropriate follow-up care. She added that it was not clear how using the devices without following the recommendations might affect safety.

The two largest plastic surgery associations said they strongly advise members to adhere to the guidelines. Mentor Corp., which makes silicone implants, said it supports the product labeling. The other implant manufacturer, Allergan Inc., said it encourages physicians and patients to follow the recommendations and that it offers training for physicians to understand them.

About 330,000 cosmetic breast augmentations were performed in the United States in 2006, up from about 291,000 in 2005, according to statistics from a survey of doctors conducted by the American Society of Plastic Surgeons. These numbers do not include patients who had implants for reconstruction after breast cancer.

Surgery not covered

Breast augmentation surgery can cost from $4,500 to $10,000, including silicone implants -- which are more expensive -- or saline implants, surgeons' fees and operating-room costs. Health insurance does not typically cover cosmetic procedures.

But even as more women choose breast augmentation, surgeons have been engaged in a heated debate over how best to monitor and treat silicone patients.

Doctors must go over a checklist about risks and follow-up care with every patient seeking silicone implants, according to manufacturers' guidelines. And in advising them to get an MRI every two years starting the third year after the surgery, doctors said they also inform patients of an additional cost of $1,000 to $2,200, which is unlikely to be covered by insurance.